Continuation Electroconvulsive Therapy (C-ECT) for Relapse Prevention in Major Depression
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Purpose
OBJECTIVES:
To evaluate the comparative efficacy and security of Continuation Electroconvulsive Therapy associated with pharmacotherapy versus pharmacotherapy alone in the prevention of depressive relapse.
METHODS:
Demographic and clinical variables will be collected and side effects scales and neurocognitive battery will be performed. Variables of efficacy: relapse percentage in both groups in one year (primary variable); time without relapse. Main variable of security: occurrence of side effects and neurocognitive performance.
DESIGN: Randomized controlled clinical trial.
SAMPLE:
104 outpatients diagnosed with unipolar depression (DSM-IV-R criteria) who had remitted with a course of bilateral ECT. They will be randomized to two groups of treatment.
SETTING: Psychiatry Department at Bellvitge University Hospital.
ANALYSIS: Descriptive analysis of clinical variables; survive analysis and Cox model of regression.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Device: C-ECT Drug: PHARMACOTHERAPY |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial |
- Hamilton Depression Rating Scale 21 items (HDRS-21) [ Time Frame: One year. HDRS will be assessed in each follow-up visit (weekly the first month, fortnightly the second and third month, monthly the following 6 months and quarterly at 12 and 15 months). ] [ Designated as safety issue: No ]HDRS-21 will measure the relapse year in each group. Relapse will be defined as the reappearance of relevant symptoms after resolutin of the acute episode, measured by a scoring in HDRS-21 between 15-17 over two following measures or a HDRS>18 score in a single measure.
- Mini-Mental State Examination (MMSE 35) [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]Assessment of general cognitive status.
- UKU - Adverse effects rating scales [ Time Frame: Every assessment (weekly, fortnightly, monthly and quarterly) till the end of follow-up. ] [ Designated as safety issue: Yes ]Qualitiative measure of side effects in each treatment group.
- Demographical Data Memory (MEDABI-20) [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]Descriptive measure of cogntive status.
- Rey Figure [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]Measure of visual perception, concentration and memory.
- Trail Making Test A [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]Measure of attention and cognitive flexibility.
- Trail Making Test B [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]Measure of attention and cognitive flexibility.
- Stroop Test [ Time Frame: Basal, at 8 months and 12 months ] [ Designated as safety issue: Yes ]Measure of selective attention, cognitive flexibility and processing speed as well as executive function.
- Direct and inverse digits (WAIS, Weschler Adults Intelligence Sacle). [ Time Frame: Basal ] [ Designated as safety issue: No ]Measure of general intelligence and attention
- Vocabulary WAIS (Weschler Adults Intelligence Scale) [ Time Frame: Basal ] [ Designated as safety issue: No ]Measure of general intelligence
- Frequency Hospitalization Quotient [ Time Frame: One year ] [ Designated as safety issue: No ]Measure of number of hospitalization per year.
- Hospital Day Quotient (HDQ) [ Time Frame: One year ] [ Designated as safety issue: No ]Number of days hospitalized per year.
| Estimated Enrollment: | 104 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: C-ECT and Pharmacotherapy
Consolidation treatment with ECT will be considered finished after 9 months of being started, at which time patients will stay only on the pharmacological treatment they already had. The study will be completed within 15 months of patient inclusion (six months after the end of C-ECT). Patient assessment and follow-up will be conducted by participant researchers. Blind rater will conduct clinical and adverse effects ratings. A neuropsychologist will conduct neuropsychological assessments.
|
Device: C-ECT
C-ECT will be administered through a Thrymatron System IV device (Somatics, LLC, ISO 13485:2003). Electrode placement will be bilateral and energy administered during consolidation treatment will be same used in the acute episode. C-ECT will be given weekly for the first month, fortnightly for the following two months and monthly during the next 6 months. A total of 14 C-ECT sessions will be given over 9 months of treatment. Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Drugs will be obtained as usually from the National Health System and will be prescribed according to data sheet and it will have a duration of 15 months. Other Names:
|
|
Active Comparator: Pharmacotherapy
Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet.
|
Drug: PHARMACOTHERAPY
Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet and will have a 15 month duration.
Other Names:
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Detailed Description:
Major Depressive Disorder (MDD) is a severe psychiatric disorder that affects more than 6 million people in our country and has a life prevalence of 8.9% for men and 16. 5% for women (Haro et al, 2007). Besides, in recent decades, its incidence is increasing (Kessler et al, 2004). MDD has high recurrence rates and 25% of the cases develop chronification. Moreover it can occur at any age leading to severe disability. The majority of studies published in this field demonstrated the efficacy of antidepressant treatment in a short or medium-term basis, but there is a lack of long-term clinical trials regarding antidepressant efficacy and published ones present methodological problems. At present, a line of fundamental research in therapeutics includes pragmatic studies because they can answer crucial and specific questions in clinical practice. Therefore, the aim of this project is to conduct a pragmatic, parallel, randomized trial with 2 treatment arms to answer a key question of great interest to psychiatrists: Is it more effective to extend the use of ECT as maintenance therapy (together with drug therapy) rather than just using drug therapy in patients that previously required an acute ECT course for a depressive episode? This study is a controlled randomized clinical trial that starts after the remission of the acute depressive episode. Once patients have clinically remitted they will be randomized in two groups:
- C-ECT together with pharmacotherapy (same treatment used in the acute episode).
- Maintenance pharmacotherapy treatment (same treatment used in the acute episode).
Consolidation treatment with ECT will be considered finished after 9 months of being started, at which time patients will stay only on the pharmacological treatment they already had. The study will be completed within 15 months of patient inclusion (six months after the end of C-ECT). Patient assessment and follow-up will be conducted by participant researchers. Blind rater will conduct clinical and adverse effects ratings. A neuropsychologist will conduct neuropsychological assessments.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- MDD diagnosis by DSM IV-TR.
- ECT requirement during acute episode. Therapeutic indication will be based on clinical criteria, following APA guidelines. During the acute episode, patients will be controlled by the usual clinical care team.
- Complete clinical remission (HDRS < or = 7 across two weeks).
- Appropriate intellectual level that allows adequate communication.
- Women of childbearing potential must use contraceptive methods.
- Signed Consent form.
- Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.
- To be in maintenance ECT program.
- To receive ECT during the previous three months of the acute episode.
- Pregnancy or breastfeeding.
Exclusion Criteria:
- Other axis I or II diagnosis by DSM-IV-TR, except for nicotine dependence.
- To be in maintenance ECT program.
- To receive ECT during the previous three months of the acute episode.
- Pregnancy or breastfeeding.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01305707
| Contact: Mikel Urretavizcaya Sarachaga, MD, PhD | 0034932607661 | murretavizcaya@bellvitgehospital.cat |
| Spain | |
| Hospital Universitari de Bellvitge | Recruiting |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Corporació Sanitària Parc Tauli | Recruiting |
| Sabadell, Barcelona, Spain, 08208 | |
| Contact: Erika Martinez Amoros, MD 0034937231010 akirema22@hotmail.com | |
| Principal Investigator: Erika Martinez Amoros, MD | |
| Sub-Investigator: Juan D Barbero Valverde, MD | |
| Sub-Investigator: Gemma Garcia Pares, MD, PhD | |
| Hospital Universitari de Bellvitge, IDIBELL | Recruiting |
| Barcelona, Spain, 08907 | |
| Contact: Mikel Urretavizcaya, MD, PhD 0034932607922 murretavizcaya@bellvitgehospital.cat | |
| Sub-Investigator: Veronica Gálvez Ortiz, MD | |
| Sub-Investigator: Eva Real Barrero, MD | |
| Sub-Investigator: Nuria Custal Teixido, MD | |
| Sub-Investigator: Virginia Soria Tomas, MD, PhD | |
| Principal Investigator: Mikel Urretavizcaya Sarachaga, MD, PhD | |
| Sub-Investigator: Aida De Arriba Arnau, MD | |
| Principal Investigator: | Mikel Urretavizcaya Sarachaga, MD, PhD | Hospital Universitari de Bellvitge, IDIBELL | |
| Principal Investigator: | Èrika Martínez Amorós, MD | Corporacion Parc Tauli |
More Information
No publications provided
| Responsible Party: | Mikel Urretavizcaya Sarachaga, Psychiatrist, MD, PhD, Hospital Universitari de Bellvitge |
| ClinicalTrials.gov Identifier: | NCT01305707 History of Changes |
| Other Study ID Numbers: | TECHUB2007 |
| Study First Received: | February 28, 2011 |
| Last Updated: | October 18, 2014 |
| Health Authority: | Agency of Medicines and Sanitary Products: Spain European Medicines Agency: Europe |
Keywords provided by Hospital Universitari de Bellvitge:
|
Consolidation ECT Pharmacotherapy Efficacy Depression |
Prevention Electroconvulsive therapy Drug therapy |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mental Disorders Mood Disorders Antidepressive Agents Antipsychotic Agents Aripiprazole Citalopram Clomipramine Clorazepate Dipotassium Dexetimide Duloxetine Fluoxetine Imipramine |
Lithium Lorazepam Mirtazapine Nortriptyline Olanzapine Paroxetine Quetiapine Risperidone Sertraline Venlafaxine Adrenergic Agents Adrenergic Antagonists Adrenergic Uptake Inhibitors Adrenergic alpha-Antagonists Analgesics |
ClinicalTrials.gov processed this record on March 01, 2015